[The potential impact of a critical medicines list on preventing and mitigating drug shortages in Hungary].

Abstract

Introduction: The impact of the stockpiling obligation of medicinal products imposed by Decree no. 16/2024. (III. 11.) of the Ministry of Interior on publishing the list of critical medicines on drug shortages has not been investigated. Objective: The aim of our study was to evaluate the appropriateness of this policy measure on tackling drug shortages by the partial use of quantitative methods. Method: The active pharmaceutical ingredients appearing on the list of critical medicines was compared to the ones identified using the public list of drug shortages covering the past year before the publication of the list of critical medicines. This was enriched with pharmaceutical consumption data, duration of the shortage, price increases and the availability of substitutional medicinal products to observe self-regulation mechanisms. Results: 605 active ingredients were reported to have a shortage in the time frame of our study; the number of active ingredients appearing on the list of critical medicines was 312; the number of active ingredients in both sets were 190. 415 active ingredients only appeared on the list of reported shortages; 99 active ingredients only appeared on the list of critical medicines. The median duration of shortages was 10 months and 11 months, respectively. Among those active ingredients reported to have a shortage and also appearing on the list of critical medicines, a substitutional medicine was authorized in 17.4% of the cases; a price increase was initiated for 5.3% of all cases; contingency arrangements were made in 7.4% of the cases. Discussion: Stockpiling obligations for wholesalers are common policy measures in the European Union. However, other member states use multiple policy tools (such as easing administrative and pricing procedures, maintaining a stakeholder forum) in parallel to mitigate drug shortages. Conclusion: The list of critical medicines might reduce the frequency of short-term drug shortages for a limited scope of medicinal products. Without appropriate self-regulation mechanisms, further policy interventions are needed to tackle shortages in a broader range of medicines, as well as to mitigate the risk of long-term drug shortages. Orv Hetil. 2024; 165(34): 1325–1331.